Infusion Pump May Have Blocked Vents

WASHINGTON -- The FDA has issued a Class I recall of the Medtronic MiniMed Paradigm Insulin Infusion Sets due to a safety issue that can occur if insulin or other fluids come into contact with the inside of the tubing connector.

If this occurs, it can temporarily block the vents that allow the pump to properly prime. This may result in too much or too little insulin being delivered by the device, which can lead to serious illness.

The recall affects 37 models of Medtronic's Paradigm infusion sets.

The FDA cautioned patients to not insert the infusion set if they noticed anything unusual during the priming process, such as insulin continuing to drip from the tip of the set's cannula after priming.

The recall was initiated on June 7 by Medtronic. The company released an urgent medical device safety notification to healthcare professionals. The safety issue applies to all Medtronic infusion sets designed for use with Medtronic Paradigm family infusion pumps.

A second notice from the company was distributed on June 10 to customers and distributors that warned of the safety issue and offered mitigation instructions. This notice may be accessed via Medtronic's website.

Class I recalls affect products with a reasonable risk of serious adverse events or death with use.

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